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Starting soon Observational

Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

NCT06680310 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-12-01
Last updated
2024-11-08

Condition(s) studied

Sjogren SyndromeDry SyndromeLupusSclerodermaRheumatoid Arthritis

Study summary

Prospective multicenter cross-sectional study evaluating ultrasound of the main salivary glands (2 parotid and 2 submandibular) in patients with Sjögren's disease compared with patients with other connective diseases (rheumatoid arthritis (RA), lupus, scleroderma) and control patients (patient with dry syndrome without the above-mentioned autoimmune disease).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Major patients * Patients fulfilling Sjogren criteria (2012 and 2016 American-European criteria) or Lupus according to ACR 2019 criteria or RA according to ACR/EULAR 2010 criteria or scleroderma according to ACR-EULAR 2013 classification criteria or control patient (patient with dry syndrome felt without pre-cited autoimmune disease). Exclusion Criteria: * Uncooperative patient who has refused to participate in the study. * Patients unable to understand the protocol, under guardianship or curatorship. * Patients not affiliated to the French Social Security system.

Primary outcome measure(s)

  • Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations — Baseline
    The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients.

Trial sites (1)

FacilityCityRegionStatus
CHU Brest Brest France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680310 on ClinicalTrials.gov ↗ ← All trials in France